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METORY：为临床试验量身定制的基于需求驱动的区块链动态同意平台的开发。

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials.

作者信息

Huh Ki Young, Jeong Sang-Un, Moon Seol Ju, Kim Min-Ji, Yang Wooseok, Jeong Myeonggyu, Song Ildae, Kwak Yong-Geun, Lee SeungHwan, Kim Min-Gul

机构信息

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea.

Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, South Korea.

出版信息

Front Med (Lausanne). 2022 May 13;9:837197. doi: 10.3389/fmed.2022.837197. eCollection 2022.

DOI:10.3389/fmed.2022.837197
PMID:35646983
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9136007/
Abstract

The recent advent of the dynamic consent concept intensified the data integrity issue in clinical trials. Incorporating blockchain technology into a dynamic consent platform can be a feasible solution. Due to various clinical trial settings, a demand-driven development strategy is required. We developed a blockchain-based dynamic consent platform named METORY tailored for clinical trials. The platform consisted of three parts: web and mobile application user interface, study management platform, and blockchain platform. Hyperledger Fabric, an enterprise-grade private blockchain framework, was used to integrate blockchain into the study consent platform. We conducted user acceptance tests and applied feedback to the improvement of the platform. Identity and role-based access control was constructed by combining mobile-application-based certificate system and access control functionalities in Hyperledger fabric. Data were encrypted using SHA-256 prior to transmission to blockchain server and TLS protocol was used for in-transit encryption. File-system level encryption was separated implemented within the security measures from Amazon RDS. Users' experience in the clinical trial was acceptable in the ease and usefulness of the platform.

摘要

动态同意概念的近期出现加剧了临床试验中的数据完整性问题。将区块链技术整合到动态同意平台中可能是一个可行的解决方案。由于各种临床试验设置，需要一种需求驱动的开发策略。我们开发了一个名为METORY的基于区块链的动态同意平台，专门针对临床试验进行了定制。该平台由三个部分组成：网络和移动应用程序用户界面、研究管理平台和区块链平台。企业级私有区块链框架Hyperledger Fabric被用于将区块链集成到研究同意平台中。我们进行了用户接受度测试，并将反馈应用于平台的改进。通过结合基于移动应用程序的证书系统和Hyperledger fabric中的访问控制功能，构建了基于身份和角色的访问控制。在传输到区块链服务器之前，数据使用SHA-256进行加密，并使用TLS协议进行传输过程中的加密。文件系统级加密在来自亚马逊RDS的安全措施中单独实现。用户在临床试验中的体验在平台的易用性和实用性方面是可以接受的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/ae29e6c64acf/fmed-09-837197-g0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/2c0cdfc4b19e/fmed-09-837197-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/b2b3fd4bf631/fmed-09-837197-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/54a90fc78b7c/fmed-09-837197-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/8d1254d3c9fb/fmed-09-837197-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/33b5b456d7fc/fmed-09-837197-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/ae29e6c64acf/fmed-09-837197-g0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/2c0cdfc4b19e/fmed-09-837197-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/b2b3fd4bf631/fmed-09-837197-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/54a90fc78b7c/fmed-09-837197-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/8d1254d3c9fb/fmed-09-837197-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/33b5b456d7fc/fmed-09-837197-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/848d/9136007/ae29e6c64acf/fmed-09-837197-g0006.jpg

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